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The management and oversight of clinical trials agreement contracts are still handled through spreadsheets or document management systems ill equipped for an efficient CTA lifecycle.
Worldwide, over 10,000 study-sites begin negotiations on a Clinical Trial Agreement (CTA) every month, and more often than not, the management and oversight of these contracts are still handled through spreadsheets or document management systems ill equipped for an efficient CTA lifecycle. This non-productive process leads to excessive manual tracking (often by high-paid lawyers), lack of transparency and ultimately slow contract execution. Each day that a contract sits on someone’s desk before becoming fully executed is another day’s delay in patient enrollment and study timeline slippage. With a top-200 prescription drug selling for $1,776,000/day (2010 sales -drugs.com), these delays cost sponsors a lot of lost opportunity cost for a process that garners insufficient attention.
There are readily implementable clinical IT and business solutions that can expedite the contract negotiation process, and below are proven methods that have been shown to enhance CTA management productivity.
The management of Clinical Trial Agreements has long been an overlooked area in the clinical study process, however, clinical operations groups can easily improve productivity if done right. With advancements in cloud technology, and innovations in business process and resource management, IT departments and software vendors can give contract management teams the tools they need to manage the CTA process efficiently; lawyers can spend more time on negotiation and contract language and less time buried in reporting and chasing stalled agreements. Implementing this solution enables management to not only receive the information they need, but, also achieve faster contract execution and experience cost savings. For CROs, it’s happy clients and a more efficient legal team. Everybody wins with an efficient and effective CTA lifecycle.
Gordon Jones is the CEO of Acorn Applications LLC, and can be reached here.
Moe Alsumidaie is the President & Chief Scientific Officer of Annex Clinical, and can be reached here.
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